Reported Sep 12, 2018 · Terminated
GE LOGIQ E9 ultrasound system Product Usage: The device is intended for use by a qualified physician for ultrasound…
GE Medical Systems Ultrasound & Primary Care Diagnostics, LL
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Medical Systems Ultrasound & Primary Care Diagnostics, LL · 9900 W Innovation Dr · Milwaukee, WI · 53226-4856
Is this the product you have?
- GE LOGIQ
- E9 ultrasound system Product UsageThe device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transrectal; Transvaginal; Transesophageal and Intraoperative (abdominal, thoracic and vascular)
- Lot codes and dates
- Each consignee have one serial numbers assigned
- Amount recalled
- 12,426 (4,717 US; 7,709 OUS ALL PRODUCTS)
This recall covers 8 products
The agency filed one notice per product. You are reading one of them; the other 7 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
The system side of the power cord may break and expose the electrical conductors leading to the risk of shock.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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